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  5. Indian River Tobacco Traders LLC - 08/31/2015
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WARNING LETTER

Indian River Tobacco Traders LLC


Delivery Method:
UPS and Electronic Mail

Recipient:
Indian River Tobacco Traders LLC

8235 Mason Drive, Suite G

Newaygo, MI 49337
United States

Issuing Office:
Center for Tobacco Products

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

AUG 31, 2015

VIA UPS and Electronic Mail
 
Indian River Tobacco Traders LLC
d/b/a Indian River Tobacco Traders, Inc.
Outpost 1
8235 Mason Drive, Suite G
Newaygo, MI 49337
info@irttsales.com
  
 
WARNING LETTER
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.indianrivertobacco.com and determined that the cigarette tobacco and/or roll-your-own tobacco products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarette tobacco and roll-your-own tobacco, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
 
FDA has determined that the website, http://www.indianrivertobacco.com, offers for sale cigarette tobacco and/or roll-your-own tobacco products. Section 900(4) of the FD&C Act (21 U.S.C. § 387(4)) defines “cigarette tobacco” as “any product that consists of loose tobacco that is intended for use by consumers in a cigarette.” Section 900(15) of the FD&C Act (21 U.S.C. § 387(15)) defines “roll-your-own tobacco” as “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.” 
 
We note that on your website, you present the following loose tobacco products containing the package description pipe tobacco but are offered for sale or distribution as cigarette tobacco and/or roll-your-own tobacco: Athey, Ramback, and Three Sails. The overall presentation of these products on your website strongly suggests that they are intended for use in a cigarette, likely to be offered to consumers for making cigarettes, and/or appear to be suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes. Specifically, the website describes these products as “dual purpose,” or “duel purpose” (sic). Therefore, your products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
           
FDA has determined that several of your products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution. Additionally, FDA has determined that Athey Old Timers Blend is adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because it purports to contain a natural or artificial characterizing flavor. 
 
Modified Risk Tobacco Product Violations
 
Our review of your website,http://www.indianrivertobacco.com, revealed that you sell or distribute the following cigarette tobacco and/or roll-your-own tobacco products, which are described as being “mild,” “light,” or using similar descriptors: Athey 14 oz Bag (described as “mild”), Ramback 3.5 oz Cup (described as “a favorite among light smokers” and “so mild”), and Three Sails 14 oz Bag (described as “light”).
 
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). 
 
The above-listed products are modified risk tobacco products because the website uses the descriptors “mild,” “light,” or similar descriptors to describe these products. Because these products are sold or distributed to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
 
Flavored Cigarette Violations
 
Additionally,our review of your website,http://www.indianrivertobacco.com, revealed that you offer for sale or distribute the following cigarette tobacco and/or roll-your-own tobacco product: Athey Old Timers Blend 3.5 oz Cup (whiskey).
 
This product is purported to contain an artificial or natural flavor that is a characterizing flavor of the product. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
 
[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice . . . that is a characterizing flavor of the tobacco product or tobacco smoke.
 
Cigarette tobacco and/or roll-your-own tobacco that is distributed or sold in the United States in violation of this provision is adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).  Thus, your flavored cigarette tobacco and/or roll-your-own tobacco productisadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, the cigarette tobacco and/or roll-your-own tobacco product does not contain a characterizing flavor, it is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as itslabeling or advertising is false or misleading because it makes the representation that the product contains, for example, whiskey as a characterizing flavor of the tobacco product.
 
Conclusion and Requested Actions
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. 
 
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), any in other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
 
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Please note your reference number, RW1500315, in your response and direct your response to the following address:
 
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 
If you have any questions about the content of this letter, please contactEle Ibarra-Pratt at (301) 796-9235or via email at CTPCompliance@fda.hhs.gov.   
 
 
Sincerely,
 
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
VIA Electronic Mail
 
cc:

Indian River Tobacco Traders LLC
webmaster@indianrivertobacco.com   
cheryl@irttsales.com  
 
Enom, Inc.
abuse@enom.com
 
Volusion
abuse@volusion.com